Manufacturing
Where you can improve your lead times, he says, is by scaling up. The problem, of course, is that creating products that require such forensic diligence on a larger scale requires more skilled hands. “The folks I’ve spoken to at the companies involved in this say their single biggest rate limiter right now for production is that they can’t get enough people to do the manufacturing,” says Janssen. Add to this that the FDA expects to approve between ten and 20 cell and gene therapies a year by 2025, and it becomes abundantly clear why manufacturers are desperate for talent.
What about automation?
As with the manufacturing sectors in numerous other industries, there’s no shortage of buzz around the prospect of automating parts of the cell and gene therapy production cycle. It’s not without good reason either. As well as the increase in speed and output gained through automating, a more standardised manufacturing process can tackle one of the biggest issues the sector currently has – variability. “What I think is the right pinkness of the media, or confluency of the cells, will be different to what you think, or what person x, y or z thinks,” says Kusena. “We can all have the same years of experience and still see things differently.” Unlike in a more traditional manufacturing setting, where human error might result in the scrapping of one of thousands of products, in cell and gene manufacturing, it can be the difference between a patient receiving their last resort in time. In worst-case scenarios, Kusena says the process can fail completely, carrying with it a cost to the business that can run into tens of thousands of pounds due to the high price tags on reagents used. In his own research, Kusena found that the seeding density of cells into a growth medium can be particularly sensitive, causing many of the batch failures he says are a big problem in the current state of manufacturing.
Automation has the potential to improve this failure rate by “removing the need for people to think,” says Kusena, whose employer is a start-up actively working on a machine that can do just this. “That’s not a negative thing, because when you’re manufacturing, you want your process to be as standardised and robust as possible,” he adds. “You don’t want to have to make decisions that are probably going to cause variation, because we’re working with a biological entity that is already variable itself.”
The ideal scenario envisioned by Kusena is one in which the skill level required for cell and gene therapy manufacturing is reduced by implementing automation guided by a rules-based set of protocols, with the process overseen by the PhDs and research associates that currently do much of the manual
World Pharmaceutical Frontiers /
www.worldpharmaceuticals.net
labour. The caveat here is that facilities aren’t going to automate overnight. Sarah Stoll is director of Project Farma, a cell and gene therapy manufacturing consultancy, and she also extols the virtues of automation, even extending them to include the ability to create a digital record of manufacturing, something that’s becoming more sought after by regulators. But although she sees the sector increasing its use of automation “day by day”, she says it still has a long way to go before the process stops being a predominately manual one.
Even experts’ opinions can differ, but automating cell and gene production helps to eliminate variability.
“There’s a little over 1,200 clinical trials worldwide, and about half of those are in the US. Over 100 of those are in phase III, so we’re getting really close to getting more approved.”
Sarah Stoll, Project Farma
The right people for the job Until automation reaches anywhere close to a saturation point in the cell and gene therapy manufacturing market, companies producing these next-generation pharmaceuticals are going to be fighting the same staffing battle they have for years, with the predicted influx of new therapies heaping on even more pressure. “There’s a little over 1,200 clinical trials worldwide, and about half of those are in the US,” says Stoll. “Over 100 of those are in phase III, so we’re getting really close to getting more approved.” Meanwhile, Stoll says the skill shortage isn’t slowing down, especially with Covid creating a demand for similarly skilled personnel in vaccine production.
In the UK, the springboard organisation CGT Catapult runs apprenticeships aimed at school leavers to create a pipeline of talent into the
10–20
New cell and gene therapies expected to be approved by the FDA per year by 2025. Food and Drug Authority
37
Kateryna Kon/
www.shutterstock.com
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